U.S. patent number 11,351,377 [Application Number 16/865,363] was granted by the patent office on 2022-06-07 for intra-oral appliances and systems.
This patent grant is currently assigned to The Cleveland Clinic Foundation, XII Medical, Inc.. The grantee listed for this patent is THE CLEVELAND CLINIC FOUNDATION, XII Medical, Inc.. Invention is credited to Anthony V. Caparso, Kelly B. Emerton, Francis A. Papay, Charles P. Steiner.
United States Patent |
11,351,377 |
Papay , et al. |
June 7, 2022 |
Intra-oral appliances and systems
Abstract
An intra-oral appliance to power and/or communicate with a
neurostimulator is provided. The intra-oral appliance can include a
teeth covering configured to fit over mandibular incisor, canine
and/or premolar teeth of a human being and a remote controller in
the form of a housing extending posteriorly from and operably
connected to the teeth covering. The housing can include a power
source, a coupling coil configured to transmit power to the
neurostimulator and configured to receive power from an external
charger, and electrical circuitry operably connected to the
coupling coil and the power source.
Inventors: |
Papay; Francis A. (Westlake,
OH), Emerton; Kelly B. (Bay Village, OH), Steiner;
Charles P. (Pepper Pike, OH), Caparso; Anthony V. (North
Ridgeville, OH) |
Applicant: |
Name |
City |
State |
Country |
Type |
THE CLEVELAND CLINIC FOUNDATION
XII Medical, Inc. |
Cleveland
Cleveland |
OH
OH |
US
US |
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Assignee: |
The Cleveland Clinic Foundation
(Cleveland, OH)
XII Medical, Inc. (Cleveland, OH)
|
Family
ID: |
1000006352227 |
Appl.
No.: |
16/865,363 |
Filed: |
May 3, 2020 |
Prior Publication Data
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Document
Identifier |
Publication Date |
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US 20200346010 A1 |
Nov 5, 2020 |
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Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
Issue Date |
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62842890 |
May 3, 2019 |
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Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61N
1/37252 (20130101); A61N 1/3611 (20130101); A61N
1/36078 (20130101); A61N 1/0548 (20130101); A61N
1/36128 (20130101); A61N 1/40 (20130101) |
Current International
Class: |
A61N
1/36 (20060101); A61N 1/05 (20060101); A61N
1/372 (20060101); A61N 1/40 (20060101) |
Field of
Search: |
;607/42 |
References Cited
[Referenced By]
U.S. Patent Documents
Primary Examiner: Layno; Carl H
Assistant Examiner: Kalinock; Jane C
Attorney, Agent or Firm: Levine Bagade Han LLP
Parent Case Text
CROSS-REFERENCE TO RELATED APPLICATIONS
The present application claims priority to U.S. Provisional
Application No. 62/842,890, filed on May 3, 2019, the entirety of
which is incorporated by reference herein.
Claims
What is claimed is:
1. An intra-oral appliance to treat sleep disordered breathing in a
patient comprising: a teeth covering shaped in an arch and
configured to fit over mandibular incisor, canine and/or premolar
teeth of a human being; a remote controller comprising a
substantially ellipsoidal housing extending posteriorly from a
midline of the arch of the teeth covering and operably connected to
the teeth covering, the remote controller sized and dimensioned to
be positioned, in its entirety, in the intra-oral cavity and
configured to be positioned underneath the ventral surface of the
tongue in an operable configuration, the housing comprising: a
power source; a coupling coil configured to transmit power to a
neurostimulator and configured to receive power from an external
charger; and a control circuit operably connected to the coupling
coil and the power source.
2. The intra-oral appliance of claim 1, wherein the coupling coil
is an induction coil.
3. A neurostimulator system comprising the intra-oral appliance of
claim 1 and further comprising: the neurostimulator comprising a
stimulating electrode and an antenna or coil configured to receive
power and/or stimulation parameters from the remote controller.
4. The system of claim 3, further comprising the external charger
comprising a charging coil configured to transmit power to the
coupling coil of the remote controller, the coupling coil
configured to charge the power source.
5. The system of claim 3, wherein the power source is a
rechargeable battery.
6. The system of claim 3, further comprising a personal electronic
device in communication with the remote controller, the personal
electronic device including software to control one or more
stimulation parameters associated with the neurostimulator.
7. The system of claim 6, further comprising a programming device
configured to deliver stimulation instructions to the remote
controller, the programming device being in communication with the
remote controller and/or the personal electronic device.
8. The system of claim 3, wherein the system is configured to
receive a sensed physiological parameter or a related symptom of
sleep disordered breathing.
9. The system of claim 8, wherein the system is configured to
automatically control one or more stimulation parameters in
response to the sensed physiological parameter or related
symptom.
10. The system of claim 3, wherein the neuro stimulator comprises
an implant.
11. The system of claim 10, wherein the implant comprises: a body
having a proximal end portion and a distal end portion; a
stimulating electrode connected to the body; and an antenna or coil
to receive power and/or stimulation parameters, wherein the antenna
or coil is connected to the body.
12. The system of claim 11, further comprising at least one sensor
attached to the body of the implant and configured to detect a
physiological parameter or a related symptom of sleep disordered
breathing.
13. The system of claim 10, further comprising a fixation structure
that facilitates fixation of the body of the implant in or adjacent
a target tissue.
14. The system of claim 13, wherein the fixation structure is
deployable and is housed within the body of the implant in a
non-deployed configuration and, when actuated, forms a surface
structure on the body that facilitates fixation in or adjacent the
target tissue.
15. The intra-oral appliance of claim 1, wherein the housing
comprises a thickness of less than or equal to 5 mm.
16. The intra-oral appliance of claim 1, wherein the housing
comprises the ellipsoidal diameter of less than or equal to 3
cm.
17. The intra-oral appliance of claim 1, wherein the teeth covering
and the housing form an integral one-piece device.
Description
TECHNICAL FIELD
An intra-oral appliance for powering and/or communicating with a
neurostimulator is provided.
BACKGROUND
Preterm obstructive sleep apnea (OSA) is highly prevalent,
affecting one in five adults in the United States. One in fifteen
adults has moderate to severe OSA requiring treatment. Untreated
OSA results in reduced quality of life measures and increased risk
of disease including hypertension, stroke, heart disease, etc.
Continuous positive airway pressure (CPAP) is a standard treatment
for OSA. While CPAP is non-invasive and highly effective, it is not
well tolerated by patients. Patient compliance for CPAP is often
reported to be between 40% and 60%. Surgical treatment options for
OSA, such as anterior tongue muscle repositioning, orthognathic
bimaxillary advancement, uvula-palatal-pharyngoplasty, and
tracheostomy are available too. However, they tend to be highly
invasive (result in structural changes), irreversible, and have
poor and/or inconsistent efficacy. Even the more effective surgical
procedures are undesirable because they usually require multiple
invasive and irreversible operations, they may alter a patient's
appearance (e.g., maxillo-mandibulary advancement), and/or they may
be socially stigmatic (e.g., tracheostomy) and involve extensive
morbidity.
SUMMARY
Devices to power and/or communicate with a neurostimulator are
provided herein. In an aspect, an energy delivery system is
provided to activate and communicate with an indwelling
neurostimulator placed proximate to a distal arborization of the
hypoglossal nerve, within the genioglossus muscle, for example. An
energy delivery system can include a removable intra-oral appliance
that includes a remote controller for a neurostimulator. The energy
coupling provides sufficient power to enable the neurostimulation
device, using telemetric protocols, to modulate the delivery of a
neurostimulation signal to a target site, such as, for example, the
hypoglossal nerve. An intra-oral appliance can include a teeth
covering configured to fit over mandibular incisor, canine and/or
premolar teeth of a human being. The intra-oral appliance can also
include a remote controller that is a hermetically sealed housing
extending posteriorly from and operably connected to the teeth
covering. The housing can comprise a power source, a coupling coil
configured to transmit power to a neurostimulator and configured to
receive power from an external charger, and a control circuit
operably connected to the coupling coil and the power source.
Neurostimulation systems are also provided that include an
intra-oral appliance and a neurostimulator along with other
components such as an external charger, a personal electronic
device, and/or a programming device. Intra-oral appliances and
systems including same can be used to improve sleep disordered
breathing, including OSA, in patients suffering therefrom.
BRIEF DESCRIPTION OF THE DRAWINGS
FIG. 1 is top view of an intra-oral appliance according to an
aspect of the present disclosure.
FIG. 2 is a top view of an intra-oral appliance positioned on a
patient's teeth according to an aspect of the present
disclosure.
FIG. 3 is a top schematic view of an intra-oral appliance in
spatial relation to implanted neurostimulators according to an
aspect of the present disclosure.
FIG. 4 is a block diagram illustrating components of a
neurostimulator and a remote controller of an intra-oral appliance
according to an aspect of the present disclosure.
FIG. 5 is a side view of a neurostimulator according to an aspect
of the present disclosure.
FIG. 6 is a side view of a neurostimulator according to an aspect
of the present disclosure.
FIG. 7 is a schematic illustration of a neurostimulator implanted
in a target site of a patient's body according to an aspect of the
present disclosure.
FIG. 8 is a block diagram of components of a neurostimulation
system according to an aspect of the present disclosure.
FIG. 9 is a perspective view of a re-charging device according to
an aspect of the present disclosure.
DETAILED DESCRIPTION
Devices for powering and/or communicating with neurostimulators are
provided herein. The present disclosure refers to the term
"substantially" with respect to certain shapes and configurations.
By "substantially" is meant that the shape or configuration of the
element need not have the mathematically exact described shape or
configuration but can have a shape or configuration that is
recognizable by one skilled in the art as generally or
approximately having the described shape or configuration. The
terms "anterior" and "posterior" are used herein with reference to
a patient in a standard anatomical position. Further, as used
herein with respect to a described element, the terms "a," "an,"
and "the" include at least one or more of the described element,
including combinations thereof, unless otherwise indicated.
Further, the term "or" refers to "and/or" and "combinations
thereof" unless otherwise indicated. By "integral" or "integrated"
is meant that the described components are fabricated as one piece
or multiple pieces affixed during manufacturing or the described
components are otherwise not separable using a normal amount of
force without damaging the integrity (i.e. tearing) of either of
the components. A normal amount of force is the amount of force a
user would use to remove a component meant to be separated from
another component without damaging either component. As used herein
a "patient" includes a mammal such as a human being.
An intra-oral appliance that includes a remote controller for
powering and/or communicating with a neurostimulator is provided
herein. Referring to FIGS. 1 to 3, intra-oral appliance 38 is
configured to sit on the lower jaw or mandible of a patient
suffering from sleep disordered breathing and temporarily affixes
to the posterior surface of the teeth and rests underneath the
tongue. In particular, intra-oral appliance 38 can comprise a
mouthguard or teeth covering 39 having a substantially
semi-circular shape configured to fit over a patient's mandibular
incisor, canine and/or premolar teeth. Intra-oral appliance 38 can
further include a remote controller 49 in the form of a housing 41
extending posteriorly from and operably connected to teeth covering
39 and configured to be positioned underneath the ventral surface
of the tongue in an operable configuration (i.e. when therapy is
ready to be initiated and the intra-oral appliance is worn by the
patient). The teeth covering and housing can be an integral
one-piece device. The housing can have a substantially ellipsoidal
shape and can have a thickness of less than or equal to
approximately five millimeters (mm) and an ellipsoidal diameter of
less than or equal to three centimeters (cm). The geometry of
intra-oral appliance naturally encourages the lower jaw to be
positioned more anterior than normal thereby assisting with the
opening of the patient's airway.
FIG. 2 is a schematic illustration of a top view of intra-oral
appliance 38 depicting internal components of intra-oral appliance
38. Remote controller 49 can house a rechargeable or removable
power source 43 and one or more coupling coils 45 arranged in a
power/communication circuit such that power source 43 can provide
electrical power for exciting coupling coils 45. Exciting coils 45
create a magnetic field that can reach one or more implanted
neurostimulators 47. Neurostimulators 47 can include a coil and/or
an antenna that is excited by the electromagnetic field generated
by coupling coils 45, which induces a current in the
neurostimulator coil/antenna. Through inductive coupling, the
induced current can be used to power the implanted neurostimulators
47 for an extended period of time. For example, a rechargeable
battery can provide as much as eight hours of power to a
neurostimulator through this inductive coupling configuration.
It should be noted that neurostimulators 47 are individual
components that are separate from the intra-oral appliance 38. FIG.
3 illustrates the relative spatial relationship between
neurostimulators 47a and 47b and intra-oral appliance 38. The
neurostimulators are implanted at a target site of neural or
neuromuscular tissue, as described in more detail below. In the
illustrated example configuration of the system, the intra-oral
appliance 38 has no stimulating or sensing electrodes, as its
purpose is to wirelessly power the implanted neurostimulators 47a
and 47b through inductive coupling. However, the intra-oral
appliance could have stimulating and/or sensing electrodes to
stimulate tissue with the oral cavity and sense parameters within
the oral cavity, such as tongue position, for example.
Referring to FIG. 4, according to one aspect, neurostimulators 47
can be passive devices. By this, it is meant that the stimulation
parameters with which neurostimulators 47 deliver electrical
stimulation are determined by the current induced in the
neurostimulators by remote controller 49. These stimulation
parameters can, for example, include the amplitude, frequency,
wavelength, waveform, pulse width, pulse phase, and polarity of the
electrical stimulation signal. Remote controller 49 can include a
control circuit 84, which includes, among other components, a
microprocessor and memory used to store executable code,
programming data, stimulation parameters, and other data, which the
microprocessor uses to execute the control functions described
herein. Control circuit 84 can be configured to utilize power
source 86 to supply current to coupling coil 80 that displays
signal characteristics defined by the desired stimulation
parameters. The stimulation parameters can be programmed onto
control circuit 84 via wireless communication, e.g., Bluetooth.RTM.
or Wi-Fi.RTM. radio communication. This programming can be done
through any Bluetooth enabled device, such as a smartphone, tablet
computer, notebook computer, PC, etc. Other parameters, such as
patient information, history, data logging, etc., can also be
communicated in this manner.
Control circuit 84 can supply the current to the coupling coil with
the desired signal characteristics, for example, through
pulse-width modulation ("PWM"). Coupling coil 80, excited by this
current, creates an electromagnetic field 82 that displays these
same signal characteristics. Coils/antenna 45 of the
neurostimulator are, in turn, excited by this field 82, which
causes the current induced therein to have the same or
substantially the same signal characteristics. Coils/antenna 45
form portions of a neurostimulator circuit 92 that includes a
charge storage device 94, stimulation electrodes 51, and,
optionally, a protection resistor/circuit 96. This induced current
flows charges charge storage device 94 (e.g., a capacitor), which
supplies electrodes 51. Electrodes 51 deliver the electrical
stimulation with the signal characteristics of the induced current.
It can thus be seen that, in this passive implementation of
neurostimulator 47, the signal is passed through the device as
received from remote controller 49.
In use, remote controller 49 can control neurostimulators 47 in an
open loop control scheme, as described above. Alternatively, the
neurostimulators can include sensors that provide feedback that can
be relayed back to control circuit 84 for closed-loop control.
Other devices, such as an external, wearable sensor or implantable
sensor can be used to provide feedback. In one specific example,
the sensors can be electrodes 51 or sensors implemented in
neurostimulators 47. Remote controller 49 can apply stimulation via
neurostimulators 47 according to stimulation program(s) stored in
control circuit 84 memory. Stimulation programs can include
predetermined, set programs (e.g., firmware) and adaptive, dynamic
programs (e.g., software that is configurable/adaptable). The
remote controller can select between various programs and/or
actively modify a stimulation program according to various inputs
received via Bluetooth.RTM. from a smartphone, tablet, etc. from a
patient or doctor.
The neurostimulator that is powered and communicates with an
intra-oral appliance as described herein can be an implantable
neurostimulator such as an indwelling neurostimulator as described
in U.S. Provisional Application No. 62/659,347 ("the '347
application"). The '347 application describes an injectable
implant. Referring to FIG. 5, injectable implant 10 can comprise a
body 12, at least one stimulating electrode 14a, 14b disposed on
the body, and an antenna or coil 16 that is connected to the body
for receiving power and/or stimulation parameters from a remote
controller. Injectable implant 10 can also include a deployable
fixation structure 18 that is housed within the body in a
non-deployed configuration and, when actuated, forms a surface
structure on the body that facilitates fixation in or about a
target tissue. Body 12 can comprise a hermetically-sealed structure
that has a generally tubular or cylindrical shape (e.g.,
isodiametric). In some instances, body 12 can have a hermetic
integrity such that the leak rate is less than about
5.times.10.sup.-8 atm cc/s He, and that moisture within the body
through its service life is less than about 6000 ppm. Body 12 can
include a proximal end portion 20, a distal end portion 22, and a
middle portion 24 extending between the proximal and distal end
portions. In one example, body 12 can have an outer diameter that
is less than or equal to 5 mm and, for example, less than or equal
to 2 mm. In another example, body 12 can have a length of about 50
mm or less, e.g., about 40 mm (e.g., about 30 mm), about 10 mm or 5
mm.
As also shown in FIG. 6, implant 10 can include a sensor 52 to
enable closed-loop operation of the implant. Sensor 52 can be
disposed on body 12 and be configured or programmed to detect at
least one physiological parameter, or a related symptom, associated
with sleep disordered breathing, such as OSA. In one example,
implant 10 can include an EMG sensor 52 that is capable of
detecting the electrical activity produced by a muscle. Examples of
muscles whose activity can be detected by an EMG sensor of the
present disclosure are disclosed in U.S. Pat. No. 9,757,560 to
Papay, which is incorporated by reference herein. In certain
aspects, implant 10 can include an electrode capable of stimulation
and sensing; in other words, a dual capacity electrode. The
above-described neurostimulator is only exemplary and an intra-oral
appliance can be used with other neurostimulators. In certain
embodiments, the indwelling neurostimulator is positioned at a
distal arborization 90 of the hypoglossal nerve 92 as illustrated
in FIG. 7 (implant 10 enlarged for purposes of illustration).
Additional components of a neurostimulator system 56 are
illustrated in FIG. 8 and can include intra-oral appliance 38, a
personal electronic device 76, and a programming device 78. As
shown in FIG. 8, neurostimulator 10 (which in FIG. 8 is illustrated
as an injectable neurostimulator as described above but could have
forms and configurations) can be in electrical communication (e.g.,
wireless communication) with intra-oral appliance 38 and
programming device 78 (which is illustrated as a smartphone but
could take other forms); the intra-oral appliance can be in
electrical communication (e.g., wireless communication) with
neurostimulator 10, the personal electronic device 76, and the
programming device 78; the personal electronic device 76 can be in
electrical communication (e.g., wireless communication) with the
intra-oral appliance 38 and the programming device 76; and the
programming device 78 can be in electrical communication (e.g.,
wireless communication) with the personal electronic device 76, the
intra-oral appliance 38, and the neurostimulator 10.
All or only certain components of system 56 can be portable and
adapted to be borne by a patient suffering from sleep disordered
breathing for a desired period of time. In some instances, system
56 can be borne by a subject for an acute period of time (e.g.,
during an emergency situation), for a semi-chronic period of time
(e.g., less than about a week to about 6 weeks), or for a chronic
period of time (e.g., greater than about 6 weeks). For example, the
neurostimulator can be temporarily or permanently implanted within,
on, or otherwise associated with a subject suffering from sleep
disordered breathing. The intra-oral appliance can be electrically
coupled to an indwelling neurostimulator to deliver power and
control signals to activate the neurostimulator, for example,
during an eight hour treatment period, for sleep disordered
breathing such as OSA.
Programming device 78 of system 56 can be configured and programmed
to deliver stimulation and/or control instructions to the
intra-oral appliance 38, and/or neurostimulator 10, and/or personal
electronic device 76. In one example, programming device 78 can be
configured as a dedicated, smart phone-sized unit. In another
example, programming device 78 can be configured as a smart phone
accessory dongle. In some instances, programming device 78 can be
operated manually by the patient or a caregiver. In other
instances, the programming device 78 can be battery powered and/or
directly powered, e.g., by an AC source. If powered by rechargeable
batteries, a battery charger may be an accessory to the programming
device 78.
With respect to personal electronic device 76 of system 56,
examples of personal electronic devices include smart phones and
tablets; although, it will be appreciated that personal computers
(PCs) may also be included. In some instances, the personal
electronic device can include software programmed to control one or
more stimulation and/or control parameters associated with the
neurostimulator. Additionally, or optionally, the software
comprising the personal electronic device can be programmed to
store patient therapy data, such as diary questions and patient
incentive information, and/or promote patient-to-patient
interaction. The personal electronic device can also include
software programmed to access remote data sources (e.g., Internet
websites), query certain data, and then provide stimulation
instructions to the system 56 based on the queried data. In another
example, the personal electronic device can also include software
programmed to provide the neurostimulator with customizable or
patient-triggered alerts, e.g., indicating stimulation periods and
the duration of each period, after a desired period of time after
sleep onset, or after consumption of food or water. In some
instances, the personal electronic device can be operated manually
by the patient or a caregiver.
System 56 can be configured as an open-loop or closed-loop system.
In an open-loop system, for example, a physician or the subject
may, at any time, manually or by the use of pumps, motorized
elements, etc., adjust treatment parameters of the system 56.
Alternatively, in a closed-loop system (discussed below), treatment
parameters (e.g., electrical signals) may be automatically adjusted
in response to a sensed physiological parameter or a related
symptom indicative of the extent of sleep disordered breathing,
such as OSA. In a closed-loop feedback system, a sensor that senses
a physiological parameter associated with sleep disordered
breathing, such as OSA (e.g., muscle or nerve electrical activity,
tongue position, oropharyngeal airflow, etc.) can be utilized. More
detailed descriptions of sensors that may be employed in a
closed-loop system, as well as other examples of sensors and
feedback control techniques that may be employed as part of the
present disclosure are disclosed in U.S. Pat. No. 5,716,377, which
is incorporated by reference herein.
Referring to FIG. 9, a neurostimulator system can include external
recharging device 100 that incorporates wireless charging
functionality by way of a wireless charging/coupling pad or coil
incorporated into housing 102 of external recharging cradle 100 to
re-charge an intra-oral appliance 104. Current from an internal or
external power source can flow through the coil/pad inside
recharging device 100, creating an electromagnetic field. Such an
electromagnetic field can induce current in a coupling coil (e.g.
inductive coupling) of intra-oral appliance 104 that is in
electrical communication with the intra-oral appliance's battery.
Such current can recharge the battery of the intra-oral appliance.
As such, the external recharging device can provide wireless
recharging of the remote controller of the intra-oral appliance.
The external recharging device can also provide gentle ultrasonic
or chemical cleaning of the teeth covering of the intra-oral
appliance. The cleaning can be similar to other ultrasonic or
chemical based cleaning system. The external recharging device can
include a display 106 that indicates that the charging and cleaning
function is either "off," "in progress" or "complete" by way of a
multi-color indicator, for example. The wireless recharging
function can provide a complete charge in 120 minutes using a 5V,
2A power source, for example.
Each of the disclosed aspects and embodiments of the present
disclosure may be considered individually or in combination with
other aspects and embodiments. Further, while certain features of
embodiments may be shown in only certain figures, such features can
be incorporated into other embodiments shown in other figures or
otherwise disclosed in the specification. Additionally, when
describing a range, all points within that range are included in
this disclosure. In addition, unless otherwise specified, none of
the steps of the methods of the present invention are confined to
any particular order of performance.
* * * * *